Cleared Traditional

K234098 - Mobility Scooter (C4+)

K234098 is an FDA 510(k) clearance for Mobility Scooter (C4+), manufactured by Yongkang Yile Vehicle Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K234098 · Yongkang Yile Vehicle Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2024
Decision
114d
Days
Class 2
Risk

K234098 is an FDA 510(k) clearance for the Mobility Scooter (C4+). Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Yongkang Yile Vehicle Co., Ltd. (Yongkang, CN). The FDA issued a Cleared decision on April 18, 2024 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Yongkang Yile Vehicle Co., Ltd. devices

FDA 510(k) Submission Details - K234098

510(k) Number K234098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2023
Decision Date April 18, 2024
Days to Decision 114 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 115d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INI Device Classification - Class 2, Special Controls

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Shanghai Mind-Link Consulting Co., Ltd.
Evan hu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - INI Vehicle, Motorized 3-wheeled

All 116
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K234098.
Electric Scooter (M2085, S2091)
K240272 · Guangdong Prestige Technology Co., Ltd. · Jul 2024
Mobility Scooter (W3331)
K240008 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Jun 2024
Mobility Scooter (W3431)
K240012 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · May 2024
Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT)
K231472 · Suzhou Sweetrich Vehicle Industry Technology Co., Ltd. · Jul 2023
Mobility Scooter (Models: W3431D)
K231428 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Jul 2023
Electric Scooter (Model: M2020)
K230001 · Guangdong Prestige Technology Co., Ltd. · Jul 2023